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WS-1100WS-1100PV system is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adults in a homecare environment.

The device features include the display of irregular pulse rhythm detection, the classification display of measured blood pressure values against the guideline by World Health Organization or equivalent guidelines, the personal setting for individual blood pressure target values, the two memory banks to save the measurement results with date and time of measurement and the transferring the saved results to personal computers.

Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are measured in the wrist artery using the oscillometric method. WS-1100WS-1100PV is a single-mounted device of the main unit and the cuff unit. ABS and PMMA are used for the outer housing of the main unit and the Lenticular image is printed as the positioning guide to remind the user to take correct posture for blood pressure measurement. The preformed cuff unit, which is applicable to wrist circumference approximately between 4.9 and 8.5 inches (between 125 and 215 mm), includes the inflatable bladder and the nylon shell. The device consists of the microprocessor, the pressure-frequency converter, the operation keys, the pump, the electromagnetic deflation control valve (ECV) and the display. The device is powered by two AAA alkaline batteries. The cuff, wrapped over the user's wrist, is inflated and deflated during the course of a measurement. Circuits within the cuff sense the oscillations in pressure against the cuff produced by the expansion and contraction of the arteries in the wrist in response to each heart beat. The amplitude of each pressure waves is measured, converted to millimeters of mercury, and displayed on the LCD as a digital value.

Measured blood pressure values are classified against the guideline by World Health Organization or equivalent guidelines and the classified levels are displayed in the reading display. The device compares the measured blood pressure value to the individual target value set by the user and flashes the value when it exceeds the target value.

The device also compares the longest and the shortest time intervals of the detected pulse waves to the mean time interval and flashes heart mark to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25 %.

The user of WS-1100/WS-1100PV can choose to save the measurement results in either one of two memory banks, each of which has the capacity for sixty readings, or not to save the results at the end of a measurement. The results are saved along with the date and time of the measurement and the user can review the saved readings. The device also has feature to display the saved readings taken in the morning and the evening separately. The user can also review the saved readings on a personal computer by downloading saved readings using the designated USB cable included in the product package. The application software is downloaded over the internet.

The provided text describes a 510(k) premarket notification for a Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV. It outlines the device's technical characteristics, intended use, and its comparison to predicate devices, particularly Nissei Model WS-500 Digital Wrist Blood Pressure Monitor (K003444). The document does not provide a detailed report of a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics. Instead, it refers to compliance with existing standards (IEC60601 and ANSI/AAMI SP-10) and notes a minor difference in the test protocol for wrist circumference compared to the predicate device.

Therefore, many of the requested specific details, such as a table of acceptance criteria with reported device performance, sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study results, standalone performance, and training set information, are not present in the provided text.

Based on the information available:

1. A table of acceptance criteria and the reported device performance:
   The document states that the device was tested and "fulfilled the requirements from these standards" (IEC60601 and ANSI/AAMI SP-10). However, specific numerical acceptance criteria (e.g., accuracy ranges for systolic and diastolic pressure, clinical grading based on AAMI criteria) and the corresponding reported device performance values are not provided in the text. It only generally states compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The text mentions "clinical studies performed with the subject device" but does not provide the sample size, country of origin, or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference standard (e.g., mercury sphygmomanometer) following specific protocols, rather than "experts" in the context of image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   MRMC studies are typically performed for AI-assisted diagnostic devices where human readers interpret medical images. This device is an automatic blood pressure monitor; therefore, an MRMC comparative effectiveness study in the context of human readers with AI assistance is not applicable and no such study is described. The device is standalone in its measurement function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, the device itself is a "standalone" automatic sphygmomanometer. The document states, "Blood pressure, systolic and diastolic, and pulse rate are measured in the wrist artery using the oscillometric method." The entire description of its operation indicates it functions without real-time human intervention in the measurement process. The compliance with IEC60601 and ANSI/AAMI SP-10 would involve testing this standalone performance against reference methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For blood pressure monitors, the ground truth for accuracy studies is typically established by simultaneously measuring blood pressure using a reference standard method (e.g., a mercury sphygmomanometer manned by a trained observer or another validated oscillometric device) in accordance with the protocols outlined in standards like ANSI/AAMI SP-10. The text does not explicitly state this, but it is the standard practice for such devices to meet the referenced standards.

8. The sample size for the training set:
   This device is not described as using machine learning in a way that requires a separate "training set" in the common AI sense. Its underlying algorithm for oscillometric measurement is based on established physiological principles and signal processing, not on a data-driven machine learning model that would need a large labeled training set. Therefore, this information is not applicable or not provided in the context of this device.

9. How the ground truth for the training set was established:
   As above, this is not applicable as the device's main function does not appear to rely on a trained machine learning model requiring a ground-truthed training set.

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